Body Weight-Supported and Virtual Reality Gait Training in Stroke Patients

Official title

A Comparative Evaluation of the Effectiveness of Body Weight-Supported Forward and Backward Gait Training Versus Virtual Reality-Assisted Gait Training in Patients With Stroke

Overview

The aim of this study is to compare the effects of body weight-supported gait training that includes virtual reality-assisted dual-task applications with body weight-supported forward and backward gait training on functional capacity, gait parameters (such as step length, gait speed, and balance), cognitive functions and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility in patients with stroke

Detailed description

Stroke is a leading cause of disability worldwide and often results in motor, balance, and cognitive impairments that negatively affect functional independence and quality of life. Walking limitations are among the most common consequences after stroke and represent a major barrier to community participation. Therefore, improving gait performance and functional mobility is a primary goal of stroke rehabilitation.

Body weight-supported gait training is widely used to improve walking ability in individuals with impaired balance and reduced motor function. In recent years, rehabilitation technologies such as virtual reality-assisted gait training have been increasingly incorporated into clinical practice. Virtual reality may enhance patient engagement and promote both motor and cognitive recovery by providing interactive environments and increasing task demands.

Backward walking training has also gained attention as an alternative rehabilitation approach. Compared to forward walking, backward walking requires greater postural control and cognitive processing, similar to dual-task training, and may contribute to improvements in balance and gait performance. However, there is limited evidence directly comparing virtual reality-assisted dual-task gait training with backward walking training in patients with stroke.

This study aims to compare the effects of body weight-supported virtual reality-assisted dual-task gait training and body weight-supported forward and backward gait training on functional capacity, gait parameters, cognitive functions, and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility and functional outcomes in stroke rehabilitation.

Interventions

• Other Virtual Reality-Assisted Gait Training
  Body weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks.
• Other Backward Gait Training
  Body weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks.
• Other Forward Gait Training
  Body weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks.

Primary outcome measures

• 10-Meter Walk Test [Time frame: At baseline and after 6 weeks of intervention.]

Secondary outcome measures (12)

• 6-Minute Walk Test (6MWT) [Time frame: At baseline and after 6 weeks of intervention]
• Fugl-Meyer Assessment - Lower Extremity Motor Subscale [Time frame: At baseline and after 6 weeks of intervention]
• Functional Independence Measure (FIM) [Time frame: At baseline and after 6 weeks of intervention.]
• Berg Balance Scale (BBS) [Time frame: At baseline and after 6 weeks of intervention.]
• Montreal Cognitive Assessment (MoCA) [Time frame: At baseline and after 6 weeks of intervention.]
• Stroke-Specific Quality of Life Scale (SS-QOL) [Time frame: At baseline and after 6 weeks of intervention.]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: At baseline and after 6 weeks of intervention.]
• Foot Rotation [Time frame: At baseline and after 6 weeks of intervention.]
• Step Width [Time frame: At baseline and after 6 weeks of intervention.]
• Step Length [Time frame: At baseline and after 6 weeks of intervention.]
• Stance Phase [Time frame: At baseline and after 6 weeks of intervention.]
• Swing Phase [Time frame: At baseline and after 6 weeks of intervention.]

Eligibility criteria

Inclusion criteria

• Patients experiencing their first-ever stroke
• Patients with a post-stroke duration of more than 2 weeks
• Patients with plantar flexor muscle spasticity of the lower extremity less than grade 3 according to the Modified Ashworth Scale (MAS)
• Patients with a Brunnstrom stage of the lower extremity greater than 2
• Patients who are able to stand independently or under supervision for at least 2 minutes for standing assessments
• Patients who are able to walk at least 10 meters independently or under supervision, with or without an assistive device, for walking assessments
• Patients with sufficient cognitive function to understand study instructions (Mini-Mental State Examination \[MMSE\] score > 23)
• Patients with stable medical and psychological conditions
• Patients who are willing to participate in the study

Exclusion criteria

• Patients with bilateral hemispheric lesions
• Patients with severe cardiovascular or musculoskeletal conditions that prevent walking (e.g., fixed ankle contracture)
• Patients using a permanent urinary catheter, or those with pressure ulcers or urinary and/or fecal incontinence
• Patients with unilateral neglect
• Patients with neurological conditions other than stroke that may affect balance performance (e.g., Parkinson's disease, epilepsy, meningitis, cerebellar disorders, vertigo, dizziness, polyneuropathy) or musculoskeletal disorders (e.g., severe low back pain, knee disorders)
• Patients with severe visual, hearing, or speech impairments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara, Çankaya, Türkiye (Türkiye), 06800 Gaziler Physical Medicine and Rehabilitation Tra — Ankara

Identifiers

NCT: NCT07550270 · E2-25-13626

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗